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Scrambler therapy treatment: the importance of examining clinically meaningful improvements in chronic pain and quality of life |
Nayback-Beebe A, Panula T, Arzola S, Goff B |
Military Medicine 2020 Jan;185(Suppl 1):143-147 |
clinical trial |
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
INTRODUCTION: Calmare scrambler therapy (ST) interferes with pain signal transmission by using nerve fibers to convey a message of normality to the central nervous system. This prospective, double-blinded, randomized trial had three aims. First, we tried to determine ST's effectiveness in reducing chronic neuropathic pain symptoms and analgesic medication use in military service members, when compared to sham treatment. Next, we examined its effect on reported mental and physical health-related quality of life. Finally, we sought to describe participant perceptions of treatment effectiveness. MATERIALS AND METHODS: Forty-seven subjects were randomized to receive ten 30-minute active ST or sham treatments. Data were collected at baseline, posttreatment, and 1-month follow-up. RESULTS: The groups showed no statistically significant differences in pain scores, medication use, or mental or physical health-related quality of life with active versus sham treatment. However, both produced clinically meaningful reductions in pain and improvements in physical health-related quality posttreatment that was sustained at 1-month follow-up. Ninety percent of the blinded sample described the treatment intervention as a partial or complete success. CONCLUSION: ST is no better than sham treatment in decreasing pain. Yet, patient perceptions of treatment effectiveness are equally important in chronic pain treatment.
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